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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015002
Receipt No. R000017449
Scientific Title studies on the Pathogenesis of Burning Mouth Syndrome
Date of disclosure of the study information 2014/09/01
Last modified on 2018/03/05

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Basic information
Public title studies on the Pathogenesis of Burning Mouth Syndrome
Acronym Studies on the Pathogenesis of BMS
Scientific Title studies on the Pathogenesis of Burning Mouth Syndrome
Scientific Title:Acronym Studies on the Pathogenesis of BMS
Region
Japan

Condition
Condition Burning Mouth Syndrome
Classification by specialty
Radiology Anesthesiology Oral surgery
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elucidate the pathogenesis of BMS
Basic objectives2 Others
Basic objectives -Others Response to the quantitative stimuli
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Specific pain-related sites with fMRI
Diffusion of brain signaling by DTI
Key secondary outcomes Volumetry of brain structures in BMS patients

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 BMS group: Intervention is applied only on the examination date. Thermal stimuli of 49C and 40 are applied four times each on the right palm or right side of the lower lip.
Interventions/Control_2 Control group: Intervention is applied only on the examination date. The same stimulation to the BMS group is repeated same times at the right palm or right side of the lower lip.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
38 years-old <
Age-upper limit
68 years-old >=
Gender Female
Key inclusion criteria Sore tongue or mouth
Feel burning pain in the oral cavity
Key exclusion criteria Those who are taking anxiolytic drugs or antidepressants.
Those who are suffering from brain diseases.
Those who have inflammatory diseases in the oral cavity.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Shinozaki
Organization Nihon University School of Dentistry
Division name Dept of Oral Diagnostic Sciences
Zip code
Address 1-8-13 kandasurugadai, chiyoda-ku, Tokyo, Japan
TEL 03-3219-8089
Email shinozaki.takahiro@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Shinozaki
Organization Nihon University School of Dentistry
Division name Dept of Oral Diagnostic Sciences
Zip code
Address 1-8-13 kandasurugadai, chiyoda-ku, Tokyo, Japan
TEL 03-3219-8089
Homepage URL
Email shinozaki.takahiro@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Dentistry
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Radiology,Nihon University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 日本大学医学部板橋病院

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 31 Day
Last modified on
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017449

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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